BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA* 28 INSTR. W/TILT-TOP*

    MDR report key: 5201578 · Received November 4, 2015

    Report

    Report Number
    3006451981-2015-00267
    Event Type
    Injury
    Date Received
    November 4, 2015
    Date of Event
    October 8, 2015
    Report Date
    October 13, 2015
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) NO REINFORCEMENT MATERIAL WAS USED. DEVICE RETURNED 11/12/2015. PMA 510(K): K062850. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE RETURNED 11/12/2015. POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. VISUAL AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT AND A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    PROCEDURE: OPEN SIGMOIDECTOMY. THIS WAS A SECOND SURGERY FOR RECURRENT SIGMOID COLON CANCER. SURGEON FIRED EGIA60AMT NEAR THE PREVIOUS RESECTED AREA AND THE FIRING WAS SUCCESSFUL. THE ANASTOMOSIS WAS DONE WITH CEEA28. AFTER THE FIRING, THE SURGEON CHECKED THE SITE AND FOUND THAT THE STAPLES OF THE DORSAL PART WERE NOT PLACED. ONLY ONE DONUT RING WAS CONFIRMED. THE SURGEON MADE AN ADDITIONAL RESECTION, SUTURING MANUALLY AND BUILDING A STOMA. CURRENT PATIENT STATUS IS GOOD. GENDER: NOT PROVIDED. AGE AND WEIGHT: NOT PROVIDED. OPERATING TIME EXTENDED: MORE THAN 30 MIN. ADDITIONAL TISSUE RESECTION: YES. TISSUE DAMAGE: NO. NOTHING FELL INTO THE CAVITY. NO BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731277 PREMIUM PLUS CEEA* 28 INSTR. W/TILT-TOP* IMPLANTABLE STAPLE GDW COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN 111987 S4BC001X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S